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Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN
XT transcatheter heart valve system
Nikolaus A. Haas 1,2, Ronald Giacomo Carere 3, Oliver Kretschmar 4, Eric Horlick 5, Josep Rodés-Cabau 6, Daniël de Wolf 7, Marc Gewillig 8, Michael Mullen 9, Anja Lehner 1, Cornelia Deutsch 10, Peter
Bramlage 10, Peter Ewert 11
1. Department of Pediatric Cardiology and Pediatric Intensive Care, LMU München, Germany. Email:
[email protected]; [email protected]
2. Centre for Congenital Heart Defects, Heart and Diabetes Centre Bad Oeynhausen, Ruhr University
Bochum, Bad Oeynhausen, Germany
3. St. Paul’s Hospital, Vancouver, Canada. Email: [email protected]
4. University Children’s Hospital Zurich and University Hospital Zurich, Switzerland. Email:
5. Toronto General Hospital, Toronto, Canada. Email: [email protected]
6. Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Email:
7. Gent University Hospital, Belgium. Email: [email protected]
8. ZU Gasthuisberg, Belgium. Email: [email protected]
9. The Heart Hospital, London, UK. Email: [email protected]
10. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Email:
[email protected]; [email protected]
11. Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Centre Munich,
Technical University Munich, Germany. Email: [email protected]
Correspondence
Prof. Dr. Nikolaus A. Haas
Department of Pediatric Cardiology and Pediatric Intensive Care, Medical Hospital of the University
of Munich, Marchioninistrasse 15, 81377 München, Germany
Tel.: +49 89 440073941; Fax: +49 89 440073943; email: [email protected]
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Funding
This work was supported by an unrestricted educational research grant that was provided by
Edwards Lifescience, Nyon, Switzerland to IPPMed.
Competing Interests
Peter Bramlage is the representative of the Institute for Pharmacology and Preventive Medicine
(IPPMed), Cloppenburg, Germany.
Keywords: pulmonary valve, congenital heart disease, percutaneous pulmonary valve implantation,
SAPIEN XT
Journal: Int. J. Cardiol. Article type: Clinical Paper Words: 3,349 Abstract: 237
Figures: 0 Tables: 4 Supp. tables: 1 Supp. figures: 2 References: 18
Version: 14.06.2017
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ABSTRACT
Background: Patients with congenital or acquired heart defects affecting the pulmonary valve and
right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in
significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation
(PPVI). Though studies have previously reported the safety and efficacy of the early generation
transcatheter heart valves (THVs), data on more recent devices are severely lacking.
Methods and Results: We performed a multinational, multicentre, retrospective, observational
registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46
patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%),
and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was
high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and
10.9%, respectively). At 30 days post-procedure, NYHA class had improved significantly (90.6% were
at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at
baseline to 5.0% at 30 days, and the calculated peak systolic gradient had decreased from 45.2 (SD ±
21.3) mmHg to 16.4 (SD ± 8.0) mmHg, with these values remaining low up to 2 years.
Conclusions: The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common
anatomies in patients with conduits, as well as those with native pulmonary valves or transannular
patches. Continued data collection is necessary to verify long-term findings.
Clinicaltrials.gov identifier: NCT02302131
Keywords: pulmonary valve, congenital heart disease, percutaneous pulmonary valve implantation,
SAPIEN XT
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1 INTRODUCTION
Malfunctioning pulmonary valves and alterations of the right ventricular outflow tract (RVOT) are
frequent in many congenital heart defects. Typical examples include Tetralogy of Fallot (ToF), double
outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus
(TA), transposition of the great arteries (TGA) with PS (Rastelli’s Operation), absent pulmonary valve
syndrome (Miller-Lev-Paul), and the Ross Procedure for aortic valve disease.
Surgical correction involves the repair or replacement of the native RVOT using biological valves such
as homografts, bioprostheses, or xenografts. These valve corrections frequently become
dysfunctional within 3 to 20 years after the primary intervention, depending on patient’s age and
size. This results in the requirement for a further pulmonary valve replacement procedure. An
emerging, less invasive treatment option that aims to reduce the considerable morbidity associated
with repeat operations is percutaneous pulmonary valve implantation (PPVI).1, 2
Until recently, the Medtronic Melody and Edwards SAPIEN transcatheter heart valves (THVs) were
the only registered devices for this purpose, with the Melody valve available in diameters of 18, 20,
and 22 mm, and the Edwards SAPIEN valve being available in diameters of 23 and 26 mm.3-6 On-going
developments in THV design have led to the next generation SAPIEN XT being available in sizes of 20,
23, 26, and 29 mm (for further details see Supplementary Table 1); however, there is a clear need for
data on the new valve technology. For this reason, we began to retrospectively collect the available
data on SAPIEN XT implants in the pulmonic position, and to follow the identified patients within the
structured environment of a multicentre registry. We aimed to describe patient experiences, and to
document the feasibility and safety of using the SAPIEN XT THV for PPVI.
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2 METHODS
Pulmonic XT is an investigator-initiated, multicentre, observational registry collecting data on
patients undergoing PPVI using the SAPIEN XT technology (Supplementary Figure 1). The project was
registered with clinicaltrials.gov in November 2014 and assigned the registration number
NCT02302131. Enrolment was carried out either retrospectively or at the time of the procedure, with
a retrospective and/or prospective follow-up, depending on the time of recruitment relative to
implantation. All patients provided written informed consent and the respective ethics committees
at each centre granted approval prior to patient documentation. The study was performed in
accordance with the Declaration of Helsinki and its amendments.
2.1 Centres
Based on information provided by the core group of participating centres and Edwards Lifesciences,
we estimated that approximately 23 centres globally (excluding the United States) had performed at
least one PPVI using SAPIEN XT technology, with an approximate total of 92 patients receiving the
valve (estimated range 77 to 120). We approached all 23 centres in November 2014 to initiate data
collection. These included centres in Europe (Belgium, Switzerland, Germany, Netherlands, UK,
Sweden, Italy, France), the Middle East (Israel, Saudi Arabia), North America (Canada), and Australia.
2.2 Patients
Patients with a clinical indication for PPVI who had undergone or were undergoing the procedure
using the SAPIEN XT THV were eligible, provided that they supplied signed data release and informed
consent. So as to cover the broadest possible spectrum of patients undergoing PPVI, no exclusion
criteria were stipulated.
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2.3 Endpoints
The endpoints of this registry were selected in order to evaluate the feasibility and safety of
implanting a SAPIEN XT THV in the pulmonic position. The procedural and clinical outcome data
collected were based on the standards of care for PPVI at each individual participating site.
Examinations may include (but are not limited to) physical assessments, ECG, exercise testing,
laboratory results, X-rays, angiograms, CT/MRI scans, and transthoracic and/or transoesophageal
echocardiography.
Short-term outcomes included right ventricular (RV) and pulmonary artery (PA) pressures, maximum
flow velocity RVOT, degree of pulmonary regurgitation, peak gradients, procedural success, and
length of hospitalisation (from admission to discharge). Long-term outcomes included changes in
New York Heart Association (NYHA) class; peak oxygen consumption (VO2); anaerobic threshold (AT);
device function; and evidence of structural valve deterioration, including stent fracture. Safety
outcomes were device malfunction; arrhythmia; coronary compression; neurologic impairment;
conduit/RVOT rupture; stent dislocation/THV dislocation; bleeding complications; need for surgical
correction; endocarditis of the implanted valve; and any cardiovascular events, including death,
myocardial infarction, coronary compression, pulmonary embolism, and stroke/transient ischemic
attack (TIA).
2.4 Data collection
Authors collectively designed a case report form to accommodate the broadest possible spectrum of
clinical situations in which PPVI may be indicated. Data collection was paper-based, with
investigators transferring the obtained data (via letter, fax, or email) to the coordinating centre at the
Institute for Pharmacology and Preventive Medicine (IPPMed, Cloppenburg, Germany). Double data
entry was carried out by data managers to transfer the information to the Pulmonic XT database.
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Follow-up time points were defined as follows: 30 days (post intervention up to and including 30
days), 6 months (more than 30 days and up to and including 6 months), 1 year (more than 6 months
and up to and including 1 year), and 2 years (more than 1 years and up to and including 2 years).
2.5 Statistics
For categorical variables (e.g. gender) frequency distributions are given. For numerical variables (e.g.
patient age) means with standard deviations (SD) and medians with ranges are given. Statistical
analysis was performed using SPSS Statistics 23.0 (SPSS, Inc., Chicago, IL).
3 RESULTS
A total of eight centres participated in the registry. Five of the 23 approached centres were
unresponsive to the invitation to participate, five declined participation, and five did not deliver data.
Up until May 31st 2017, the 8 participating centres provided data on a total of 46 patients (range 1 to
21 patients per centre). This corresponds to 50.5% of the 91 patients estimated to have received an
implant up to this time point. Follow-up was 89.1% at day 30 (n=41), 65.2% at 6 months (n=30),
41.3% at 1 year (n=19), and 41.3% at 2 years (n=19). Three patients died during the extended follow-
up (>30 days).
3.1 Patient characteristics
At baseline, the mean age was 29.0 (SD ± 14.1) years (range 9-64 years, median 27.5 years) and
28.3% were female (13/46) (Table 1). The majority of patients (27/46; 58.7%) had ToF as the
underlying primary diagnosis, followed by 5 patients with truncus arteriosus (10.9%) and 4 patients
who had undergone a Ross Procedure (8.7%). Of the two patients with simple PS as a primary
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diagnosis, one also had tricuspid stenosis and an atrial septal defect. The most frequent RVOT
anatomy prior to valve implantation was stentless xenograft (16/46; 34.8%). Further anatomies were
homograft (8/46; 17.4%), transannular patch (6/46; 13.0%), native outflow tract (5/46; 10.9%) and
others (such as Carpentier-Edwards, Hancock etc.; 11/46; 23.9%). The majority of patients were
either NYHA class II (52.4%) or NYHA III (35.7%).
3.2 Procedural characteristics
There was a strong preference for the transfemoral access route (93.5%), with a jugular access route
selected for only three patients (6.5%; Table 2). The RVOT was pre-stented in 42 patients , with 19
being stented before and 22 stented on the day of the procedure (no information on the time of
stenting in one patient). The majority received one stent (69.6%) and the most frequently chosen
stent type was a CP bare stent (38.1%). Before pre-dilation, the minimal RVOT diameter was 16.6 (SD
± 4.6) mm, increasing to 22.8 (SD ± 3.3) mm after pre-dilation. The 26 mm SAPIEN XT was the most
frequently chosen valve size (n=26; 56.5%), followed by the 23 mm valve (n=10; 21.7%) and 29 mm
valve (n=8; 17.4%), with only 4.3% (n=2) receiving the smallest 20 mm valve. In 23.9% of patients
(11/46), the SAPIEN XT was implanted into a previously implanted bioprosthesis (Symbion in 3
patients, Mitroflow in 2, Carpentier-Edwards Perimount in 2, and Medtronic in 1, other in 3). In these
11 patients, the principal diagnosis was ToF alone (5 patients), followed by history of Ross Procedure
(2), pulmonary atresia with VSD (1) and without VSD (1), truncus arteriosus (1), and pulmonary
stenosis (1). Mean total procedural time was 147.8 (SD ± 55.0) minutes, with a fluoroscopy time of
38.4 (SD ± 30.1) minutes and a mean contrast volume of 171.5 (SD ± 134.4) ml.
3.3 Periprocedural and long-term outcomes
Procedural success, defined as a single valve implanted in the intended location, was 93.5% (Table 3).
An example of a successfully implanted valve can be seen in Supplementary Figure 2. Periprocedural
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complications were transient in one patient, with a significant paravalvular leak that was managed
without a need for conversion to surgery but with a new stent and a SAPIEN XT 26 mm valve. The
patient was clinically stable (NYHA class I) at follow-up, with trivial pulmonary regurgitation. In
another two patients, conversion to surgery was necessary due to valve dislocation. In a
retrospective analysis, valve dislocation occurred due to inadequate measurement of the pre-stented
outflow tract, resulting in an inadequate valve size within a large RVOT. No periprocedural mortality
occurred.
Three deaths occurred during follow-up, but were not valve-related: one at 3 months due to life-
threatening comorbidities, and the other at 5 months due to multiple organ failure resulting from
complications after surgical aortic valve replacement for severe aortic insufficiency, which had
already been apparent prior to PPVI.
3.4 Functional outcomes
After PPVI, an improvement in heart failure was seen (Table 4). While 38.1% of patients enrolled in
the registry were at NYHA class III–IV prior to intervention, this declined to 13.0% 6 months after the
procedure. Accordingly, an improvement of pulmonary and tricuspid regurgitation was noted, with
no or trivial pulmonary regurgitation in 92.5% of patients at follow-up day 30, and 85.7% after two
years. The peak systolic gradient (4Vmax2) over the pulmonary and tricuspid valves decreased
markedly after PPVI; however, peak systolic gradients over the RVOT remained substantially lower
than baseline at 2 years. Results regarding oxygen consumption and anaerobic threshold were
difficult to interpret owing to small patient numbers.
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4 DISCUSSION
There are few published reports on use of the SAPIEN XT THV in PPVI for patients with pulmonary
valve and RVOT dysfunction. The data gathered in the present registry suggest that implantation of
this device in a wide range of given anatomies and different diameters of the RVOT leads to
substantial improvements in haemodynamic profiles, with low complication rates. Thus, the SAPIEN
XT appears to have a high level of procedural safety and efficacy when implanted in the pulmonary
position in an international, real-world setting.
4.1 Haemodynamics
A significant reduction in the proportion of patients experiencing moderate/severe pulmonary
regurgitation was seen following PPVI (5.0% at day 30 compared to 76.1% at baseline) which
persisted up to 2 years. This marked drop is consistent with that reported in previous studies2-5, 7, 8,
and supports the case for the long-term efficacy of PPVI with the SAPIEN XT. Concurrently, the mean
peak systolic RVOT gradient at 30 days post-PPVI in the present study had dropped by 29 mmHg
relative to baseline. This is similar to the magnitude of post-procedural improvement seen by a
number of other studies (reductions of between 18 and 30 mmHg)2-5, 8-10, including one solely
evaluating PPVI in patients undergoing valve-in-valve procedures.7 Of these studies, those assessing
long-term hemodynamic outcomes also reported a continued, progressive reduction in this gradient
over the subsequent 6–12 months.3, 5, 7, 9 In the present study, the peak systolic gradient (4Vmax2)
remained markedly lower than the baseline value at all follow-ups. The finding that the mean peak
RVOT gradient was 16.4 mmHg at 30 days is particularly encouraging given recent evidence that a
post-procedural RVOT gradient below 25 mmHg is associated with longer periods of freedom from
intervention10, and a reduction in conduit gradient is an independent predictor for increased exercise
capacity.11 Our findings are therefore consistent with the idea that PPVI results in a marked,
sustained improvement in cardiac flow for patients with a range of underlying aetiologies and RVOT
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anatomies (including those with existing bioprostheses), and provides evidence for the medium-term
efficacy of the SAPIEN XT.
4.2 Functional status
Concurrent with improvement in hemodynamic dysfunction, a large improvement in NYHA class was
observed following PPVI, with the proportion of patients in class III or IV falling from 38.1% to just
9.4% at day 30. Furthermore, a trend towards an increasing proportion of patients falling within
NYHA class I was apparent up to 2 years. In support of our findings, several other studies have also
reported a dramatic shift of patients from higher to lower NYHA classes following PPVI, accompanied
by a long-term persistence of this finding.3, 4, 8, 10, 12 The only decline in NYHA class that has been
reported was identified as being due to stent fracture or recurrent RVOT obstruction8, neither of
which was encountered in the present study. Thus, despite limited patient numbers, we can be
reasonably confident that PPVI with the SAPIEN XT results in both short- and mid-term
improvements in functional status. Future data analysis including a greater number of patients at
later follow-ups will help to confirm this.
The increased diameter of the RVOT after PPVI enables a significant increase of cardiac output under
exercise conditions, translating into a measurable increase in exercise capacity. On the other hand, in
patients with predominant pulmonary regurgitation, PPVI will result in a reduced RV volume, but
very often no considerable change in exercise capacity. In our cohort, the majority (35/46) showed
moderate / severe pulmonary regurgitation as the leading pathophysiology, therefore no major
change in exercise capacity could be anticipated.
4.3 Periprocedural complications and events
A high procedural success rate (93.5%) and low rates of periprocedural complications and adverse
events (approximately 6.5% and 10.9%, respectively) were observed in the present study. These are
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similar to those reported previously for SAPIEN devices.3, 4, 12, 13 In terms of procedural complications,
one incident of device malfunction resulting in a significant paravalvular leak that was managed
without a need for conversion to surgery and two episodes of valve dislocation (4.4% of patients)
requiring conversion to surgery were observed; in retrospect, these dislocations may have been
preventable, and may be attributed to a learning curve. The rate of valve dislocation compares
favourably to the rates reported in previous studies by Haas et al. and Kenny et al. using the SAPIEN
THV (8.8% and 13.6%, respectively).3, 4 In addition, the remaining adverse events reported herein are
minimal and included only arrhythmia requiring pacing, drugs, or cardioversion (4 patients). There
was however one report of significant bleeding at the groin catheter insertion site. Other authors
have previously reported additional complications and events such as transient cerebral plexus palsy,
pulmonary haemorrhage, ventricular fibrillation, and stent or THV migration3, 4; none of which were
seen in the current study. Standardisation of complication/event reporting would aid comparisons in
future studies. In any case, all events and complications in the present study were successfully
resolved without further complications, and the 3 deaths that occurred at >30 days post-PPVI were
considered unrelated to the procedure or device used. This may lend further evidence as to the
safety of the SAPIEN XT.
Stent fracture has been a significant concern for PPVI, though has been more often associated with
the Melody valve.2, 9, 14, 15 One study reported as much as 18% of patients experiencing this
complication up to one year, even after pre-stenting.16 Conversely, studies have consistently
reported no stent fractures in patients treated with SAPIEN valves3, 4, 12, 13, which was also the case in
the present study. This suggests that the SAPIEN XT has the same superior device integrity as
previous models and may be preferable to Melody valves in patients at risk of stent fracture, such as
those with severely obstructed RVOT conduits.14
The high mortality associated with coronary compression following valve deployment in PPVI makes
it a particular cause for concern, especially as Morray et al. reported that approximately 5% of
patients are at risk.17 In the present study, no patients experienced coronary compression, despite
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the diverse range of underlying diagnoses (including a large number of patients with ToF) and inter-
subject diversity. This reflects improvements in pre-implantation procedures that have enhanced the
safety and predictability of PPVI. Future studies to identify patients most at risk of developing
arrhythmias would further improve the safety outcomes of PPVI.
4.4 Generations of Edwards SAPIEN valves
The number of patients for whom PPVI is deemed appropriate has been severely limited by both
anatomical substrate and the restricted availability of heart valve sizes.6 In a study by Lurz et al. in
2008, 5% of patients did not meet the morphological criteria for PPVI due to incompatible RVOT
dimensions.15 In the present study, the 26 mm valve was most frequently used. This size was already
available in the previous SAPIEN range and was recognised as a welcome extension to the Melody
valve, which had previously only been expandable to sizes of 18–22 mm.4 However, 17.4% (8/46) of
patients in the present study benefitted from the availability of a 29 mm valve, a newly available size
with the SAPIEN XT range. This confirms the potential for larger valves to permit PPVI in a significant
number of patients with larger outflow tracts, as was previously suggested by Demkow et al.13 On the
other hand, 2 patients were treated with a 20 mm valve, thereby extending the potential use even to
patients with smaller RVOTs. Further extension of the available valve sizes may open up the
opportunity for PPVI to even more patients in future.
The most recent SAPIEN 3 valve has recently received FDA approval for the aortic position. This valve
is also available in 23, 26, and 29 mm sizes, and offers further potential advantages, such as an outer
skirt for minimisation of paravalvular leakage, and an improved frame design to allow smaller
crimping and higher radial strength. A recent study comparing the SAPIEN 3 and SAPIEN XT THVs for
transcatheter implantation in the aortic position has reported that the newest model is associated
with reduced platelet activation and a lesser degree of aortic regurgitation.18 Future real-world
studies will examine its potential benefits in the pulmonary position (NCT02777892).
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4.5 Study limitations
The number of patients enrolled in this registry is small. This is a commonly encountered limitation in
studies assessing PPVI, which is due to the relative novelty of the procedure and the limited
availability of patients. This was further complicated in the present study by the reluctance of sites to
participate.
There is presently little registry data available regarding the long-term effects of PPVI with the
SAPIEN XT on haemodynamics and functionality. Therefore, the sustainability of the initial positive
results is uncertain. However, our findings compare well to earlier published results of PPVI with the
SAPIEN valve2-5, suggesting validity. The on-going collection of data at later time points will help to
clarify longitudinal trends in the present study, while future studies with larger cohorts will add value
to our findings.
As a largely retrospective study, uncertainty over the reliability of procedural data is an inherent
limitation, and not all data was available for each patient. The latter was particularly evident
regarding exercise capacities. However, this problem is unavoidable in a real-world setting as the
relative rarity of patients meeting entry requirements would result in either an excessively long
prospective trial period or insufficient patient numbers. Therefore, future studies when the SAPIEN
XT is more widely utilised for PPVI are necessary to investigate aspects such as improvements in
oxygen consumption.
The observational nature of the present study led to a lack of PPVI procedure standardisation
throughout the different centres, implying that results may have been influenced by the various
management approaches. Further, because patients were retrospectively documented in this
registry, there were no information captured on patients excluded because of the proximity of the
coronary arteries to the RVOT. However, the observational design may offer several potential
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advantages over a controlled study, such as the opportunity to gain an insight into the safety and
efficacy of the valve in real-world clinical practice.
5 CONCLUSIONS
In those patients we were able to document, the SAPIEN XT had a good safety profile and a high level
of efficacy in terms of haemodynamic and functional improvement. This appears at least comparable
to the previous SAPIEN valve, with a potentially reduced complication rate. The availability of an
additional valve size for implantation in the pulmonary position has allowed PPVI to be successfully
carried out in patients with a larger conduit diameter for whom the procedure would otherwise have
been impossible. Continued data collection and initiation of larger registries in future will add weight
to our findings.
6 AUTHOR CONTRIBUTIONS
All authors, led by Nikolaus A. Haas (NH), Peter Bramlage (PB), and Michael Mullen (MM), were
involved in the conception and design of the study. PB drafted the manuscript, and all authors have
revised the article for important intellectual content. All authors gave final approval of the version to
be submitted.
6.1 Principal investigators
Nikolaus A. Haas (Munich, Germany; previously Bad Oeynhausen, Germany), Michael Mullen
(London, UK), Peter Bramlage (Cloppenburg, Germany)
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6.2 Centres with enrolled patients (Investigators)
Bad Oeynhausen, Germany 21 patients (Nikolaus A. Haas); Vancouver, Canada 7 pts (Ronald Giacomo
Carere); Zürich, Switzerland 5 pts (Oliver Kretschmar); Toronto, Canada 5 pts (Eric Horlick); Munich,
Germany 3 pts (Peter Ewert); Quebec, Canada 2 pts (Josep Rodés-Cabau); Gent, Belgium 2 pts (Daniël
de Wolf), Gasthuisberg, Leuven, Belgium 1 patient (Marc Gewillig)
7 ACKNOWLEDGEMENTS
Helen Sims (IPPMed Barcelona) provided editorial support during the preparation of this manuscript.
Andrea Gansz (IPPMed Cloppenburg) managed the conduct of the project.
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10041005100610071008100910101011101210131014101510161017101810191020102110221023102410251026102710281029103010311032103310341035103610371038103910401041104210431044104510461047104810491050105110521053105410551056105710581059106010611062
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9 TABLES
Table 1: Patient characteristics
n/N (%) / mean ± SD / median (range)
Age [years] 29.0 ± 14.1
27.5 (9–64) (N = 46)
Female gender 13/46 (28.3)
Weight [kg] 71.3 ± 20.5
68.7 (22–110) (N = 46)
Height [cm] 167.8 ± 13.8
172.5 (130–189) (N = 46)
Prior endocarditis 4/43 (9.3)
Underlying diagnosis
ToF 27/46 (58.7)
Pulmonary atresia with VSD 3/46 (6.5)
Pulmonary atresia without VSD 3/46 (6.5)
Truncus arteriosus 5/46 (10.9)
Hx of Ross Procedure 4/46 (8.7)
TGA 2/46 (4.3)
Pulmonary stenosis 2/46 (4.3)
RVOT anatomy prior to valve implantation
Native RVOT / PS 5/46 (10.9)
Transannular patch 6/46 (13.0)
Homograft 8/46 (17.4)
Stentless xenograft 16/46 (34.8)
Others (Carpentier-Edwards, Hancock etc.) 11/46 (23.9)
Legend: n, number of patients with variable; N, number of patients with data available; ToF, Tetralogy of Fallot; TGA, Transposition of the great arteries; DORV, double-outlet right ventricle; RVOT, right ventricular outflow tract; PS, pulmonary stenosis; SD, standard deviation
10631064106510661067106810691070107110721073107410751076107710781079108010811082108310841085108610871088108910901091109210931094109510961097109810991100110111021103110411051106110711081109111011111112111311141115111611171118111911201121
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Table 2: Procedural characteristics
n/N (% )/ mean ± SD / median (range)
General anaesthesia 18/46 (39.1)
Access
Transfemoral 43/46 (93.5)
Jugular 3/46 (6.5)
RVOT pre-stenting
Stent placed at the time of the procedure 22/45 (48.9)
Stent placed before day of procedure 19/45 (42.2)
Number of stents implanted
0 4/46 (8.7)
1 32/46 (69.6)
2 10/46 (21.7)
Type of stent
CP bare stent 16/42 (38.1)
CP covered stent 10/42 (23.8)
Andramed 10/42 (23.8)
Other 6/42 (14.3)
Minimal diameter before pre-dilation [mm] 16.6 ± 4.6
17.0 (6–25) (N = 37)
Minimal diameter after pre-dilation [mm] 22.8 ± 3.3
23.0 (11–28) (N = 34)
SAPIEN XT THV size implanted
20 mm 2/46 (4.3)
23 mm 10/46 (21.7)
26 mm 26/46 (56.5)
29 mm 8/46 (17.4)
Valve in valve (previously implanted bioprothesis) 11/46 (23.9)
Length of procedure [min] 147.8 ± 55.0
139.5 (45–291) (N = 44)
Fluoroscopy time [min] 38.4 ± 30.1
33.5 (5.0–113.0) (N = 40)
Contrast volume [ml] 171.5 ± 134.4
129.5 (25–470) (N = 42)
Legend: n, number of patients with variable; N, number of patients with data available; RVOT, right ventricular outflow tract; CP, Cheatham Platinum; SD, standard deviation
11221123112411251126112711281129113011311132113311341135113611371138113911401141114211431144114511461147114811491150115111521153115411551156115711581159116011611162116311641165116611671168116911701171117211731174117511761177117811791180
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Table 3: Periprocedural outcomes
n/N (%)
Procedural success* 43/46 (93.5)
Procedural complications
Device malfunction 1/46 (2.2)
Dislocation of valve during implantation requiring subsequent surgical intervention 2/46 (4.4)
Procedural adverse events
Arrhythmia with pacing, drugs or cardioversion 4/45 (8.9)
Myocardial infarction 0/46 (0.0)
Pulmonary embolism 0/46 (0.0)
Rupture requiring emergency stenting or surgery 0/46 (0.0)
Coronary compression 0/46 (0.0)
Significant bleeding 1/46 (2.2)
Significant neurologic impairment 0/46 (0.0)
Periprocedural death 0/46 (0.0)
Legend: n, number of patients with variable; N, number of patients with data available; SD, standard
deviation. *Defined as single valve implanted in intended location.
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Table 4: Functional outcome after PPVI
Baseline Day 30 Month 6 Year 1 Year 2
NYHA class
Class I 4/42 (9.5) 20/32 (62.5) 15/23 (65.2) 10/14 (71.4) 9/13 (69.2)
Class II 22/42 (52.4) 9/32 (28.1) 5/23 (21.7) 4/14 (28.6) 1/13 (7.7)
Class III 15/42 (35.7) 2/32 (6.3) 2/23 (8.7) 0/14 (0.0) 3/13 (23.1)
Class IV 1/42 (2.4) 1/32 (3.1) 1/23 (4.3) 0/14 (0.0) 0/13 (0.0)
Peak systolic gradient over RVOT [mmHg]
45.2 ± 21.3(N = 34)
16.4 ± 8.0(N = 26)
20.5 ± 8.1(N = 15)
14.7 ± 9.9(N = 6)
26.1 ± 10.6(N =10)
Pulmonary regurgitation
None/trivial 3/46 (6.5) 37/40 (92.5) 27/29 (93.3) 13/18 (72.2) 12/14 (85.7)
Mild 8/46 (17.4) 1/40 (2.5) 1/29 (3.4) 3/18 (16.7) 2/14 (14.3)
Moderate 8/46 (17.4) 2/40 (5.0) 1/29 (3.4) 2/18 (16.7) 0/15 (0.0)
Severe 27/46 (58.7) 0/40 (0.0) 0/29 (0.0) 0/18 (0.0) 0/15 (0.0)
RVSP across tricuspid valve [mmHg]
59.6 ± 19.0(N = 38)
35.0 ± 9.3(N = 33)
35.2 ± 15.1(N = 20)
33.8 ± 9.8(N = 12)
32.6 ± 12.7(N = 13)
Tricuspid regurgitation
None/trivial 16/46 (34.8) 24/39 (61.5) 10/30 (33.3) 5/17 (29.4) 6/17 (35.3)
Mild 22/46 (47.8) 10/39 (25.6) 16/30 (53.3) 10/17 (58.8) 9/17 (52.9)
Moderate 6/46 (13.0) 4/39 (10.3) 3/30 (10.0) 2/17 (11.8) 2/17 (11.8)
Severe 2/46 (4.3) 1/39 (2.6) 1/30 (3.3) 0/17 (0.0) 0/17 (0.0)
Peak oxygen consumption [ml O2/min/kg bodyweight]
30.0 ± 25.6(N = 9) - 15.8 ± 7.5
(N = 4)26.5 ± 7.5
(N = 6)22.4 ± 8.2
(N = 9)
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Anaerobic threshold [ml/min/kg] 14.6 ± 10.0(N = 5) - 13.3 ± 0.6
(N = 3)17.0 ± 6.0
(N = 6)18.5 ± 6.2
(N = 6)
Legend: Values are expressed as n / N; mean ± SD; %; range; MRI: magnetic resonance imaging; RV: right ventricular; EF: ejection fraction
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SUPPLEMENTARY FIGURE LEGENDS
Supplementary Figure 1: Native RVOT after balloon dilatation of a native and severe PS. Initially
severe Pulmonary regurgitation. Prestenting performed with an Andrastent followed by implantation
of a 26 mm SAPIEN XT valve.
Supplementary Figure 2: Edwards SAPIEN XT transcatheter heart valve for PPVI.
Supplementary Table 1: Comparison of SAPIEN XT Balloon-Expandable Transcatheter Heart Valve (Model 9300TFX) Parameters
SAPIEN XT (20 mm) SAPIEN XT (23 mm) SAPIEN XT (26 mm) SAPIEN XT (29 mm)
Tissue Thickness 0.3-0.4 0.3–0.4 mm 0.3–0.4 mm 0.4–0.5 mm
Frame height (expanded) 13.5 mm 14.3 mm 17.2 mm 19.1 mm
Frame height (crimped) 16 mm 17 mm 20 mm 22 mm
Frame shortening (deployment) 2 mm 3 mm 3 mm 3 mm
Fabric Skirt Height 6 mm 6 mm 8 mm 11 mm
Delivery system NovaFlex+ NovaFlex+ NovaFlex+ NovaFlex+
Delivery system volume 11 ml 17 ml 22 ml 33 ml
Rates burst pressure 7 atm 7 atm 7 atm 7 atm
eSheath profile (internal diameter,
unexpanded)
16-F
(5.3 mm)
16-F
(5.3 mm)
18-F
(5.9 mm)
20-F
(6.6 mm)
eSheath profile (outer diameter,
unexpanded)
6.7 6.7 mm 7.2 mm 8.0 mm
Guidewire Compatibility 0.035’’ 0.035’’ 0.035’’ 0.035’’
Minimum Access Vessel Diameter 6.0 mm 6.0 mm 6.5 mm 7.0 mm
Legend: None
